Life Sciences Breakfast Seminar with PAREXEL

Join us for a complimentary breakfast seminar on Accelerated Development and Approval Pathways

This seminar is designed to help small and emerging companies understand each of the growing number of FDA expedited pathways, their comparative benefits and implications and their barriers to access.

Just as these new pathways continue to redefine how new treatments are developed and approved, the pathways themselves are evolving rapidly. While the pathways predominate in cancer, CNS, other disease areas, for example, they are more recently being applied to an ever-growing number of therapeutic areas, including diabetes and atopic dermatitis. And although each of the pathways have seen record growth from 2012-2016, we are also now seeing clear and shifting--but curious--patterns in their use by industry, particularly in areas such as oncology.

Agenda

Breakfast: 8:30 a.m.

Program: 9:00-10:00 a.m.

Networking: 10:00-10:30 a.m.

About the Speaker

Mark Mathieu
Director of Strategic Research and Publications for PAREXEL Consulting

Mark has studied and written about the drug development and FDA new drug approval process for 31 years, and has authored numerous textbooks on the topic, including New Drug Development: A Regulatory Overview, currently the most widely read text on the U.S. new drug review and approval process.

He conducts detailed proprietary studies and consults with biopharmaceutical company clients on emerging developments and critical success factors in the drug development and approval processes. Mark has also developed PAREXEL’s Bio/Pharmaceutical R&D Statistical Sourcebook, the industry’s leading compendium featuring data and analyses on emerging and critical trends in pharma/biotech research and development.

Mark frequently conducts briefings and training sessions for managers and executives regarding the major findings of his primary research, most recently on the accelerated development and regulatory pathways available for new drugs and biologics in the United States and Europe.